MAUDE Adverse Event Report: SYNTHES MONUMENT TI END CAP T25 STRDRV 0MM EXT HUMERAL NAIL-EX SPIRAL BLADE; NAIL,FIXATION,BONE

Catalog Number 04.001.000

Device Problem Extrusion (2934)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It was reported that a humeral nail removal was performed on (b)(6) 2014 due to prominent hardware and pain.The original implant date is unknown.All hardware removed was fully intact.The patient was fully healed.The procedure was successfully completed.This report is 1 of 3 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history record revealed no complaint related anomalies.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI END CAP T25 STRDRV 0MM EXT HUMERAL NAIL-EX SPIRAL BLADE
• Type of Device: NAIL,FIXATION,BONE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3912678
• MDR Text Key: 17383661
• Report Number: 1719045-2014-10285
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK033071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.001.000
• Device Lot Number: 6895172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/03/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention